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CompletedNCT07145619QoR-TAPUpdated Aug 4, 2026

Effect of Bilateral Ultrasound-Guided TAP Block on Quality of Recovery in Cesarean Delivery Patients Receiving Intrathecal Morphine

An observational study in Postoperative Pain Management, Obstetric Anesthesia and Recovery From Anesthesia, sponsored by MEHMET GÖKHAN TAFLAN. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by MEHMET GÖKHAN TAFLAN · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
160
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

This prospective, assessor-blinded observational cohort study will investigate the effect of adding bilateral ultrasound-guided transversus abdominis plane (TAP) block to standard intrathecal morphine (ITM) analgesia on the quality of recovery in women undergoing elective cesarean delivery under spinal anesthesia. All participants will receive ITM as part of routine spinal anesthesia. The TAP group will receive an additional bilateral ultrasound-guided TAP block at the end of surgery, while the control group will not receive any additional block. Both groups will receive standardized postoperative analgesia with intravenous patient-controlled analgesia (IV PCA). The primary outcome is the quality of recovery at 24 hours postoperatively, measured using the validated Obstetric Quality of Recovery-10 (ObsQoR-10) questionnaire. Secondary outcomes include Numerical Rating Scale (NRS) pain scores, time to first breastfeeding, time to mobilization, time to hospital discharge, and total opioid consumption in the first 24 hours after surgery. Outcome assessors will be blinded to group allocation. The study aims to determine whether TAP block enhances functional recovery, reduces pain, and decreases analgesic requirements when used alongside ITM in cesarean delivery patients.

Read the detailed description

Effective postoperative analgesia is essential for optimizing maternal recovery after cesarean delivery, promoting early mobilization, and supporting breastfeeding initiation. Spinal anesthesia with intrathecal morphine (ITM) is commonly used due to its long-lasting analgesia; however, it may not provide complete abdominal wall analgesia and can be associated with opioid-related side effects. The transversus abdominis plane (TAP) block is an ultrasound-guided regional anesthesia technique that provides somatic analgesia to the anterior abdominal wall by targeting the anterior rami of the thoracolumbar spinal nerves (T6-L1). When combined with ITM, TAP block may further improve recovery quality, reduce opioid requirements, and facilitate earlier return to daily activities.

In this prospective, assessor-blinded observational cohort study, all eligible patients undergoing elective cesarean delivery under spinal anesthesia at our institution will receive ITM as part of standard practice. Participants will be managed in two groups based on postoperative analgesia:

  • TAP Group: Bilateral ultrasound-guided TAP block performed at the end of surgery in addition to ITM.
  • Control Group: ITM only, without additional regional block.

Both groups will receive standardized postoperative analgesia via intravenous patient-controlled analgesia (IV PCA). Data will be collected prospectively, and the outcome assessor responsible for postoperative evaluation will be blinded to group allocation.

Primary Outcome:

  • Quality of recovery at 24 hours postoperatively, measured using the Obstetric Quality of Recovery-10 (ObsQoR-10) questionnaire.

Secondary Outcomes:

  • Numerical Rating Scale (NRS) pain scores
  • Time to first breastfeeding
  • Time to first mobilization
  • Time to hospital discharge
  • Total opioid consumption within the first 24 hours

By analyzing these parameters, the study aims to clarify whether the addition of TAP block to ITM-based analgesia can enhance recovery quality, improve functional outcomes, reduce pain intensity, and decrease opioid consumption in cesarean delivery patients. Findings from this research could inform best practice guidelines for postoperative pain management in obstetric anesthesia.

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Conditions studied

  • Postoperative Pain Management
  • Obstetric Anesthesia
  • Recovery From Anesthesia

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Keywords

  • Cesarean delivery
  • Spinal anesthesia
  • Intrathecal morphine
  • Transversus abdominis plane block
  • Postoperative pain
  • Obstetric anesthesia
  • Quality of recovery
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In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 160 is above the median of 102 across 608 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

This is the only study on the registry with MEHMET GÖKHAN TAFLAN as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women undergoing elective cesarean delivery under spinal anesthesia with intrathecal morphine at a tertiary university hospital. Two observational cohorts will be followed: one receiving only intrathecal morphine and the other receiving intrathecal morphine plus bilateral ultrasound-guided TAP block.

Inclusion criteria

  • Female patients aged 18-45 years
  • Singleton pregnancy
  • ASA physical status II-III
  • Scheduled elective lower segment cesarean delivery under spinal anesthesia with intrathecal morphine (ITM) as standard care
  • Able to understand study procedures, provide written informed consent, and reliably use IV PCA
  • Able to complete ObsQoR-10-T assessments (with trained assistance if needed)

Exclusion criteria

Exclusion Criteria:

  • Contraindication to spinal anesthesia or TAP block (e.g., infection at injection site, coagulopathy, allergy to local anesthetics)
  • Chronic opioid use or opioid/alfa-2 agonist intolerance
  • Severe preeclampsia, HELLP syndrome, significant hepatic or renal impairment
  • Urgent or emergent cesarean section (Category 1)
  • Cognitive impairment or communication difficulty preventing accurate assessment
  • Prior major abdominal surgery (other than previous cesarean delivery)
  • Body mass index (BMI) > 40 kg/m²
  • Major psychiatric illness (e.g., major depressive disorder, generalized anxiety disorder, psychosis) that may affect pain perception or quality of recovery
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
160 participants (actual)
Patient registry
No

Groups and cohorts

  • ITM

    Patients undergoing elective cesarean delivery under spinal anesthesia with 100 µg intrathecal morphine (ITM) as part of standard care. No additional regional block will be performed. Postoperative analgesia will be maintained with intravenous patient-controlled analgesia (IV PCA) using morphine, along with multimodal analgesia.Approximately 75 participants will be enrolled in this group

    Other: Spinal Anesthesia with Intrathecal Morphine Only

  • ITM + TAP

    Patients undergoing elective cesarean delivery under spinal anesthesia with 100 µg intrathecal morphine (ITM) as part of standard care, plus bilateral ultrasound-guided transversus abdominis plane (TAP) block performed at the end of surgery. Postoperative analgesia will be maintained with intravenous patient-controlled analgesia (IV PCA) using morphine, along with multimodal analgesia.Approximately 75 participants will be enrolled in this group

    Other: Spinal Anesthesia with Intrathecal Morphine plus Bilateral TAP Block

Interventions

  • OtherSpinal Anesthesia with Intrathecal Morphine Only

    Elective cesarean delivery performed under spinal anesthesia with the addition of 100 micrograms intrathecal morphine (ITM) as part of standard clinical care. No additional regional block is performed. Postoperative analgesia is maintained with intravenous patient-controlled analgesia (IV PCA) morphine and multimodal analgesia, including scheduled paracetamol and NSAIDs as per institutional protocol.

  • OtherSpinal Anesthesia with Intrathecal Morphine plus Bilateral TAP Block

    Elective cesarean delivery performed under spinal anesthesia with the addition of 100 micrograms intrathecal morphine (ITM) as part of standard clinical care, plus bilateral ultrasound-guided transversus abdominis plane (TAP) block performed at the end of surgery. The TAP block will be performed in-plane with a high-frequency linear probe, using 0.25% bupivacaine, 20 mL per side, injected between the internal oblique and transversus abdominis muscles. Postoperative analgesia will be maintained with intravenous patient-controlled analgesia (IV PCA) morphine and multimodal analgesia, including scheduled paracetamol and NSAIDs.

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What researchers measure

Primary outcomes

  1. Obstetric Quality of Recovery-10 (ObsQoR-10) Score at 24 Hours Postoperatively

    Total score on the validated Turkish version of the Obstetric Quality of Recovery-10 questionnaire (ObsQoR-10-T), measured by a blinded assessor. Scores range from 0 to 100, with higher scores indicating better recovery.

    Time frame: 24 hours after surgery

Secondary outcomes

  1. Total Opioid Consumption in 24 Hours

    Total intravenous morphine consumption (in milligrams) recorded from PCA device logs in the first 24 hours after surgery.

    Time frame: 0-24 hours postoperatively

  2. Numerical Rating Scale (NRS) Pain Scores

    Pain intensity measured using a Numerical Rating Scale (0 = no pain, 10 = worst pain imaginable) at specified postoperative time points.

    Time frame: 0-24 hours postoperatively

  3. Time to First Breastfeeding

    Time interval in minutes from the completion of surgery to initiation of breastfeeding.

    Time frame: Assessed from end of surgery to first breastfeeding attempt, up to 24 hours

  4. Time to First Mobilization

    Time interval in hours from completion of surgery to the first mobilization with assistance or independently.

    Time frame: Assessed from the end of surgery to first mobilization attempt, up to 24 hours postoperatively

  5. Time to Hospital Discharge

    Time interval from the end of surgery until the patient is formally discharged from hospital care.

    Time frame: Assessed from the end of surgery to official hospital discharge, up to 7 days postoperatively

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Study locations

1 site
  • Samsun University Training and Research Hospital
    Samsun, Samsun 55090, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD), data dictionary, and statistical analysis code will be shared with qualified researchers upon reasonable request, after publication of the main results. Data will be available 12 months after study completion and for up to 5 years. Requests must be accompanied by a methodologically sound proposal and relevant ethics approval.

Supporting information: Study protocol, Sap, Icf, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07145619
Lead sponsor
MEHMET GÖKHAN TAFLAN
Responsible party
MEHMET GÖKHAN TAFLAN (Principal Investigator, Specialist in Anesthesiology, Samsun University) — Sponsor-investigator
First posted
Aug 28, 2025
Start date
Sep 1, 2025
Primary completion
Jul 30, 2026
Completion
Jul 30, 2026
Last update
Aug 4, 2026

Study contacts

Mehmet Gökhan Taflan, MD
principal investigator · Samsun Education and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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